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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03775525
Other study ID # GEN-602-CT-101
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 1, 2019
Est. completion date December 2023

Study information

Verified date December 2022
Source Genzada Pharmaceuticals USA, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase I/Ib study is a Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination with Capecitabine, Given Orally on a Daily Schedule in Patients with Advanced Solid Tumors or Lymphoma


Description:

This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a novel anti-cancer drug, GZ17-6.02 administered to patients with advanced solid tumors or lymphoma, which have progressed after receiving standard/approved therapy or where there is no approved therapy. This study will determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of GZ17-6.02 monotherapy and in combination with standard-of-care oncology treatments and to establish the dose of GZ17-6.02 recommended for future monotherapy and combination therapies phase II oncology clinical studies.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 127
Est. completion date December 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility General Inclusion Criteria: - Patients with a pathologically confirmed diagnosis of advanced solid tumors or lymphoma. - Tumor progression after receiving standard/approved therapies which may include chemotherapy, targeted agents, radio-immuno conjugates, check point inhibitors, where there is no approved therapy; or the patient is intolerant of standard of care or the patient declines standard of care treatment - One or more metastatic tumors measurable, or evaluable, per RECIST v1.1 Criteria for solid tumors and Lugano Criteria for lymphoma - Have an Eastern Cooperative Oncology Group (ECOG) performance status of = 1 - Life expectancy of at least 3 months - Age 18 years - Signed, written IRB-approved informed consent - A negative pregnancy test (if female) - Acceptable liver function: - Bilirubin = 1.5 times upper limit of normal - AST (SGOT), ALT (SGPT) and Alkaline phosphatase = 2.5 times upper limit of normal (if liver metastases are present, then = 5 x ULN is allowed) - Acceptable renal function: o Serum creatinine = 1.5 times institutional ULN, OR calculated creatinine clearance = 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. - Acceptable hematologic status: - Granulocyte = 1500 cells/mm3 - Platelet count = 100,000 (plt/mm3) - Hemoglobin = 9 g/dL - Urinalysis: o No clinically significant abnormalities - Acceptable coagulation status (for patients on warfarin or other anti-coagulants, a PT/PTT considered by the PI as therapeutically appropriate will be allowed): - PT within = 1.5 times normal limits - PTT within = 1.5 times normal limits - For men and women of child-producing potential, the use of effective contraceptive methods during the study - Fasting glucose = 180 mg/dL - Albumin = 3.0 g/dL within seven days of initiating protocol treatment For patients in the GZ17-6.02 plus capecitabine Phase 1b Expansion Cohort 2 (metastatic breast cancer): - Pathologically confirmed diagnosis of HER2-negative and Hormone Receptor (HR) (estrogen receptor [ER] and/or progesterone receptor)-positive metastatic breast cancer; - Had = 1 prior treatment (not including neoadjuvant or adjuvant treatment); - Are naïve to capecitabine but not necessarily to fluorouracil (5 FU); - Eligible for standard-of-care treatment with capecitabine monotherapy. - Patients in Expansion Cohort 2 with bone-only metastatic disease must have one or more lytic or a mixed lytic-blastic lesions that can be assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI). For patients in GZ17-6.02 plus capecitabine Phase 1b Expansion Cohort 3 (metastatic colorectal cancer): - Pathologically confirmed diagnosis of metastatic colorectal cancer; - Had = 2 prior treatments (not including neoadjuvant or adjuvant treatment); - Are naïve to capecitabine but not necessarily to 5 FU; - Eligible for standard-of-care treatment with capecitabine monotherapy. General Exclusion Criteria: (All patients, unless otherwise specified): - New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG. - Currently taking MAOIs - Baseline QTc exceeding 450 msec in males, 470 msec in females (using the Fridericia's formula) and/or patients receiving class 1A or class III antiarrhythmic agents; - Known active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy; - Pregnant or nursing women. - NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - Treatment with radiation therapy or surgery within 1 month prior to study entry. - Treatment with chemotherapy, targeted therapeutics (e.g. tyrosine kinase inhibitors, therapeutic antibodies, etc), or investigational therapies within 1 month, or 5 half-lives (whichever is shorter), prior to study entry (6 weeks for nitrosoureas or mitomycin C). For radiopharmaceuticals, within 1 month unless hematopoietic recovery has not returned to pretreatment baseline; - Unwillingness or inability to comply with procedures required in this protocol; - Known active infection with HIV, HTLV-1, hepatitis B, hepatitis C or other chronic viral infections that could interfere with the interpretation of study data; - Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor. - Patients who are currently receiving any other investigational agent; - Primary Central Nervous System (CNS) malignancies; - Active CNS metastases requiring treatment or radiotherapy, or which have not been confirmed stable on radiographic imaging for =30 days prior to C1D1; - Patients requiring steroids for neurological signs and symptom stabilization. - Patients who are unable to successfully discontinue all prohibited medications listed in Appendix 6; - Patients must not have received a transfusion (platelets or red blood cells) = 2 weeks prior to initiating protocol therapy. For patients in the GZ17-6.02 monotherapy Dose Escalation Cohort and patients in Expansion Cohort 1: • Patients with cow's milk allergy or with galactosemia Phase 1b Expansion Cohort 2 (metastatic breast cancer) and Expansion Cohort 3 (metastatic colorectal cancer): - Any history of coronary artery disease is exclusionary; New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on the ECG. - Any conditions or medications that are contraindicated with capecitabine dosing; - Dihydropyrimidine dehydrogenase (DPD) deficiency; - Known sensitivity to capecitabine or any of its components or to 5-FU ; - Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor o This includes prior gastrointestinal surgery that would interfere with the oral drug absorption. - Malignancy other than metastatic breast cancer (Expansion Cohort 2) or metastatic colorectal cancer (Expansion Cohort 3) that required therapy within the preceding 5 years, other than adequately treated: - non-melanoma skin cancer or in situ cancer; - another cancer that has a very low risk of interfering with the safety or efficacy endpoints of the study, must be approved by the Sponsor medical team.

Study Design


Related Conditions & MeSH terms

  • Advanced Cancer
  • Basal Cell Carcinoma
  • Breast Cancer
  • Breast Neoplasms
  • Cancer of Stomach
  • Carcinoma
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Colo-rectal Cancer
  • Cutaneous Squamous Cell Carcinoma
  • Cutaneous T Cell Lymphoma
  • Cutaneous T-cell Lymphoma
  • Gastric Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Pancreatic Cancer
  • Prostate Cancer Metastatic
  • Sarcoma
  • Solid Carcinoma
  • Solid Carcinoma of Stomach
  • Solid Tumor
  • Squamous Cell Carcinoma of Head and Neck
  • Stomach Neoplasms

Intervention

Drug:
GZ17-6.02
Super enhancer Inhibition
Capecitabine
antimetabolite

Locations

Country Name City State
United States Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Cedars-Sinai Medical Center Los Angeles California
United States Ochsner Clinic Foundation New Orleans Louisiana
United States HonorHealth Research Institute Scottsdale Arizona

Sponsors (2)

Lead Sponsor Collaborator
Genzada Pharmaceuticals USA, Inc. Translational Drug Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximum tolerated dose (MTD) As assessed by CTCAE v4.03 18 months
Primary Recommended dose of GZ17-6.02 for future phase II clinical studies 18 months
Primary Dose-limiting toxicity 18 months
Secondary Antitumor effect 18 months
Secondary Area Under Concentration Curve 18 months
Secondary Maximum Plasma Concentration (Cmax) 18 months
Secondary Time to Maximum Plasma Concentration (Tmax) 18 months
Secondary Terminal Phase Half-Life (t1/2) 18 months
Secondary Total Body Clearance (CL/F) 18 months
Secondary Apparent Volume of Distribution (Vd/F) 18 months
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